Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.

Colgate-Palmolive

Status and phase: Enrolling; Phase 3

Conditions: Plaque

Treatments: Drug: 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe; Drug: 0.022% Sodium Fluoride mouthwash; Drug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste; Drug: 0.454%Stannous fluoride toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT07398846

CRO-2025-05-PG-BTB-FL-BGS

Details and patient eligibility

About

To evaluate the efficacy of a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.

Enrollment: 135 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed Informed Consent Form.
• Male and female subjects aged 18-70 years, inclusive.
• Availability for the twelve-week duration of the clinical research study.
• Good general health based on the opinion of the study investigator
• Minimum of 20 permanent natural teeth (excluding third molars).
• Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
• Initial mean plaque index of at least 0.6 as determined by Rustogi Modification of the Navy plaque index.

Exclusion criteria

• Presence of orthodontic appliances;
• Presence of partial removable dentures;
• Oral pathology, chronic disease or tumor(s) of the soft or hard tissues of the oral cavity; 4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone);
• Five or more carious lesions requiring immediate restorative treatment;
• Use of anticonvulsants, sedatives, tranquilizers, anti-inflammatory or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
• Use of antibiotics any time during the one-month period prior to entry into the study;
• Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine) and/or on any prescription medicines that might interfere with the study outcome;
• Participation in any other clinical study;
• Self-reported pregnancy and/or breastfeeding;
• Dental prophylaxis within the past three weeks prior to baseline examinations;
• Current allergies and/or history of allergic reactions to oral care products, personal care consumer products, or any of their ingredients;
• An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours;
• Current smokers and/or a history of alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

135 participants in 3 patient groups

Test 1

Experimental group

Description:

instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 20mL for 30 secs with mouthwash provided

Treatment:

Drug: 0.454%Stannous fluoride toothpaste

Drug: 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe

Test 2

Experimental group

Description:

instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided

Treatment:

Drug: 0.454%Stannous fluoride toothpaste

Drug: 0.022% Sodium Fluoride mouthwash

Test 3

Active Comparator group

Description:

instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and manual toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided

Treatment:

Drug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste

Drug: 0.022% Sodium Fluoride mouthwash